Delay in Diagnosing Breast Cancer

This medical malpractice article address some of the legal issues presented in lawsuits arising from the delay in diagnosing breast cancer. Specifically the article addresses the Standard of Care for Evaluating and Diagnosing Breast Cancer, The American Join Commission Classification of Types of Breast Cancer, and Defenses in cases arising from the delay in diagnosing breast cancer.

MEDICAL MALPRACTICE/ DELAY IN DIAGNOSING BREAST CANCER

Delay in the diagnosis of breast cancer remains one of the most commons forms of medical malpractice. The claim arises where the physician (typically a family practitioner/ surgeon/ dermatologist/ obstetrician or gynecologist) discount or fail to recognize the severity, the physician fails to properly read a radiology scan (radiologist), or a physician or hospital fails to report the results or follow up with the patient. The cancer then grows and advances to more critical stages that requires more severe treatment (mastectomy, radiation, chemotherapy) than would have been required had the cancer been diagnosed earlier. Moreover, the cancer can infiltrate the lymph nodes and cause a greater chance of recurrence further decreasing the chance of survival.

Medical Legal Issues

The Standard of Care for Evaluating and Diagnosing Breast Cancer

The first step in any medical malpractice case is to determine whether the physician breached the standard of care. There is not one standard of care that applies to all clinical scenarios. In most cases, the patient presents to her physician complaining of a small, painless, lesion or mass she has discovered on her breast.  The standard of care will depend on the specific case (i.e., presentation of the patient, objective/ subjective findings, and follow up instructions).  However there are some general rules found in the authoritative texts and practice manuals that the majority of experts and physicians would agree with.

1. The diagnosis should be made as early as possible.
2. Yearly mammograms should be given to normal risk women over the age of 40.
3. Clinical breast exams should be given to normal risk women between the ages of 20-39 every three years.
4. If the mass does not resolve within one menstrual cycle, the physician must rule out all possibility of malignancy, usually starting with a diagnostic mammogram.
5. It should be noted that a negative mammogram does not necessarily mean that the evaluation is conclusive where there is a suspicious palpable mass.
6. Other diagnostic measures, including tissue biopsy or image guided needle biopsy, are necessary, particularly where the mass is solid.
7. Following the testing, the physician should timely interpret and communicate the test results to the patient and timely order any additional follow up or diagnostic measures;
8. The initial tumor directed treatment should be initiated within four months of diagnosis

Proximate Causation in Delay of Diagnosing Breast Cancer Cases

The causation component of the case will depend greatly on the individual case and requires the close scrutiny of a highly qualified oncologist who is familiar with all the latest clinical studies, as the data changes frequently.  This short discussion cannot address all the issues that arise in this part of the case.  The case will depend on what stage the cancer was at the time when it should have been diagnosed versus when it was ultimately diagnosed.

Many factors go into staging the cancer and developing the treatment plan for the patient. A few general rules include:

1. Cases that involve a delay of less than one year are more difficult on issues of causation.
2. The probability of metastasis to regional nodes (both axillary and intermal mammary) and to distant sites increases as tumors enlarge.
3. Tumors of 1.0 cm or less in diameter have a very low chance of recurrence.
4. Patients with ER (estrogen receptive) positive tumors have prolonged disease free survival after primary treatment, superior overall survival, and longer survival after recurrence as compared to ER negative.
5. Ductal Carcinoma In Situ (DCIS) represents a small group of pre-invasive breast cancer that can almost always be cured with local regional therapy.
6. However, cancers in women under the age of 40 are typically more aggressive and should be carefully evaluated.
7. If the delay is more than three months, cancers will get larger and more aggressive.
8. Large tumor sizes, metastasis in the lymph nodes are associated with a worst prognosis.

The American Joint Commission on Cancer of The American Medical Association Classification

1. Carcinoma In Situ: Very early breast cancer found only in a local area and in only a few areas of cells;
2. Stage I: Tumor is no larger than 2 CM (about an inch) and has not spread beyond the breast;
3. Stage II: Tumor measures from 2-5 CM (one to two inches) and has spread to lymph nodes in the underarm;
4. Stage III: Cancer is larger than 5CM an involves more of the underarm lymph nodes , and/or it has spread to other lymph nodes or other tissue near the breast;
5. Stage IV: Cancer has spread to other organs in the body, most often the bones, liver, lungs, or brain.

Defenses in Breast Cancer Cases

1. Causation: The defendants will almost always argue that the delay did not impact the treatment, the chance of recurrence, or chance of survival.  Depending on the presentation, the defense will either argue that the cancer was at a later stage when the patient first presented or it was not that far advanced when it was ultimately diagnosed.  The goal is to mitigate the damages and demonstrate that the patient is not in any worst position today due to the delay.  This argument is tougher to make the longer the delay.
2. Patient Contributory Negligence: The physician may allege that the patient was informed to follow up and call for the test results, or possibly argue that as the tumor was growing the patient failed to notice the growth and follow up when the changes were notable.  These are sensitive defenses but depending on the circumstances can be effective if the evidence supports that the patient did not accept responsibility for her own health.
3. HMO: Health Management Organizations are more involved than ever in dictating the care, particularly diagnostics scans.  Some managed care practices discourage doctors from making referrals or ordering additional diagnostic tests to rule out breast cancer.  This defense may be offered to mitigate the responsibility of the physician but may also add a new defendant in the case.
4. Patient Specific Issues (Breast Density): The physician may claim that the patient’s breast density prevented a positive reading on the mammogram or clinical evaluation.  Therefore always keep in mind that a negative mammogram is not conclusive, particularly where there are issues of breast density. This issue can be a double-edged sword where the physician stopped after ordering a mammogram.

See the following for additional information:

• American Cancer Society
• American Society of Clinical Oncology
• CancerCare
• National Cancer Institute
• National Cancer Data Base Benchmark and Survival Reports
• Surveillance Epidemiology and End Results Cancer Statistics Page
• MD Anderson Cancer Center